Events

Rappel de Device Recall Siemens Healthcare

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Siemens Healthcare Diagnostics, Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    68537
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1927-2014
  • Date de mise en oeuvre de l'événement
    2014-06-02
  • Date de publication de l'événement
    2014-06-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-02-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128153
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Cause
    Swollen acid bottles due to a trace metal contamination in the acid reagent bottles.
  • Action
    Siemens Healthcare Diagnostics issued Urgent Medical Device Recall (UMDR) to customers in the United States on June 02, 2014 and a Urgent Field Safety Notice (UFSN) issued outside the United States on June 02, 2014. These notices inform the customer of the potential for swollen acid bottles due to confirmed metal contamination. Customers with alternative lots in inventory were instructed to transition to the alternative lot upon receipt of the communication. Customers without an alternative lot of acid in inventory were informed that Siemens proactively shipped an alternative lot to their laboratory and they should transition to that lot upon its receipt. Siemens also informed customers without an alternative lot that they may continue to run and report patient results using the affected lot of acid. Questions contact your Siemens Customer Care Center or your local Siemens technical support representative.

Device

Device Recall Siemens Healthcare
  • Modèle / numéro de série
    Kit Lot Number: 454779 Exp. Date: 28 February, 2015
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of Canada, Argentina, China, Colombia, Korea, Malyasia, New Zealand, Mexico, Guatemala, and Singapore.
  • Description du dispositif
    Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 || Kit Catalog Number: 112219 || SMN: 10310026 || Intended Use: In vitro diagnostic use. Acid Regent is a component of the ADVIA Centaur and ADVIA Centaur XP instruments
  • Manufacturer
    Siemens Healthcare Diagnostics, Inc

Manufacturer

Siemens Healthcare Diagnostics, Inc
  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    USFDA